HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the... |
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TORISEL® (temsirolimus)
If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents.
Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.
TORISEL® Quick Finder
Highlights
Indications and Usage
1 INDICATIONS AND USAGE
TORISEL is indicated for the treatment of advanced renal cell carcinoma.
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Dosage and Administration
2 DOSAGE AND ADMINISTRATION
2.1 Advanced Renal Cell Carcinoma
The recommended dose of TORISEL for advanced renal cell carcinoma is 25 mg administered as an...
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Dosage Forms and Strengths
3 DOSAGE FORMS AND STRENGTHS
TORISEL (temsirolimus) is supplied as a kit consisting of the following:
TORISEL (temsirolimus) injection (25 mg/mL). The TORISEL vial contains temsirolimus at a concentration of 25 mg/mL....
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Contraindications
4 CONTRAINDICATIONS
TORISEL is contraindicated in patients with bilirubin >1.5×ULN [see Warnings and Precautions (5.2)].
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Warnings and Precautions
5 WARNINGS AND PRECAUTIONS
5.1 Hypersensitivity/Infusion Reactions
Hypersensitivity/infusion reactions, including but not limited to flushing, chest pain, dyspnea,...
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Drug Interactions
7 DRUG INTERACTIONS
7.1 Agents Inducing CYP3A Metabolism
Co-administration of TORISEL with rifampin, a potent CYP3A4/5 inducer, had no significant effect on...
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Use in Specific Populations
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
Based on findings in...
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Overdosage
10 OVERDOSAGE
There is no specific treatment for TORISEL intravenous overdose. TORISEL has been administered to patients with cancer in phase 1 and 2 trials with repeated intravenous doses as high as 220 mg/m...
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Description
11 DESCRIPTION
Temsirolimus, an inhibitor of mTOR, is an antineoplastic agent.
Temsirolimus is a white to off-white powder with a molecular formula of C56H87NO...
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Clinical Pharmacology
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
Temsirolimus is an inhibitor of mTOR (mammalian target of rapamycin). Temsirolimus binds to an intracellular protein...
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Nonclinical Toxicology
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
Carcinogenicity studies have not been conducted with temsirolimus. However,...
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Clinical Studies
14 CLINICAL STUDIES
A phase 3, multi-center, three-arm, randomized, open-label study was conducted in previously untreated patients with advanced renal cell carcinoma (clear cell and non-clear cell histologies). The...
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References
15 REFERENCES
- 1.
- OSHA Hazardous Drugs. OSHA. https://www.osha.gov/SLTC/hazardousdrugs/index.html.
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How Supplied/Storage and Handling
16 HOW SUPPLIED/STORAGE AND HANDLING
NDC 0008-1179-01 TORISEL (temsirolimus) injection, 25 mg/mL.
Each kit is supplied in a...
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Medication Guide
17 PATIENT COUNSELING INFORMATION
Allergic (Hypersensitivity/Infusion) Reactions
Patients should be informed of the possibility of serious...
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Resources
Report Adverse Event
To report an adverse event related to a Pfizer product and you are not part of a clinical trial* for this product, click the link below to submit your information: Pfizer Safety Reporting Site
*If you are involved in a clinical trial for either product, adverse events should be reported to your coordinating study site.
If you cannot use the above website to report an adverse event related to a Pfizer product, please call Pfizer Medical Information at (800) 438-1985.
You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatchor by calling
(800)-332-1088.
(800)-332-1088.